Multi-Center Phase II Study to Compare MER-101 20mg Tablets to Intravenous Zometa 4mg in Male Bisphosphonate-Naive, Hormone Refractory Prostate Cancer Patients
A Multi-Center Phase II Study to Compare MER-101 (20mg) Tablets To Intravenous Zometa 4mg in Male Bisphosphonate-Naive Hormone Refractory Prostate Cancer Patients
1 other identifier
interventional
30
3 countries
13
Brief Summary
The objective of MER-101-03 is to examine the effects of two different dosing regimens of MER-101 20mg tablets versus Zometa 4mg IV infusion once-monthly therapy. The effects will be monitored on a weekly basis by measuring various markers of bone metabolism. Patients to be enrolled will be those who have not received any previous bisphosphonate therapy. The study will be carried out on prostate cancer patients who are no longer on hormone therapy. Treatment in the study will be for a 2-month period.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Feb 2008
Shorter than P25 for phase_2
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2008
CompletedFirst Submitted
Initial submission to the registry
March 7, 2008
CompletedFirst Posted
Study publicly available on registry
March 14, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2009
CompletedFebruary 20, 2009
February 1, 2009
1 year
March 7, 2008
February 19, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Effects on 4 markers of bone metabolism
Weekly
Secondary Outcomes (1)
Brief Pain Inventory
Monthly
Study Arms (3)
B
EXPERIMENTALMER-101 20mg Tablets Regimen 1
C
EXPERIMENTALMER-101 20mg Tablets Regimen 2
A
ACTIVE COMPARATORZometa Injection
Interventions
Oral enteric coated tablets, 20mg, weekly, 8 weeks
Eligibility Criteria
You may qualify if:
- Prostate Cancer with rising PSA levels after hormone treatment and bone metastasis based on an X-ray.
You may not qualify if:
- Already be on a bisphosphonate treatment (Zometa, Fosamax, Actonel)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
Birmingham Hematology & Oncology Associates, LLC
Birmingham, Alabama, 35223, United States
Cancer Care of North Florida, P.A.
Lake City, Florida, 32055, United States
Lakeland Regional Cancer Center
Lakeland, Florida, 33805, United States
Innovative Medical Research of South Florida, Inc.
Miami, Florida, 33179, United States
Green Clinic, LLC
Ruston, Louisiana, 71270, United States
New York Urological Associates, PC
New York, New York, 10022, United States
Charleston Hematology Oncology Associates, PA
Charleston, South Carolina, 29403, United States
Cancer Outreach Associates, P.C.
Abingdon, Virginia, 24211, United States
East Tallinn Central Hospital
Tallinn, Estonia
North Estonian Regional Hospital
Tallinn, Estonia
Tartu University Hospital
Tartu, Estonia
O. Hublarovs Private Practice
Daugavpils, Latvia
P. Stradina Clinical University Hospital
Riga, Latvia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Thomas W Leonard, PhD
Merrion Pharmaceuticals, LLC
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 7, 2008
First Posted
March 14, 2008
Study Start
February 1, 2008
Primary Completion
February 1, 2009
Study Completion
February 1, 2009
Last Updated
February 20, 2009
Record last verified: 2009-02